Ethical Challenges During Clinical Trials of New Drugs

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Filgrastim (G-CSF) injections, used during chemotherapy
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We often hear about successful medical drug clinical trials, and assume that such trials frequently test "magic bullet" cures. Nearly every trial, however, requires a control group: people who are not given the new drugs and, thus, don't benefit from them if they are later proven to work.  Many doctors, researchers and patients are asking questions about the fairness of maintaining these control groups, once a given drug being tested has positive results.

Amy Harmon, a national correspondent for The New York Times, wrote an article about two cousins from California: Brandon Ryan and Thomas McLaughlin. Both were diagnosed with melanoma in 2009. Ryan and McLaughlin were admitted to a clinical trial for a new drug, PLX4032, that had shown it could safely slow the cancer's progress in some patients.  McLaughlin was given the new drug, while Ryan was assigned by a computer lottery to the control group, meaning he would receive chemotherapy.  Ultimately, Ryan died from the disease, while McLaughlin's tumors stopped growing after just two months on the drug.

So, is it unethical to prevent someone from receiving medication that has shown it can improve one's condition, simply because it will skew the results of a clinical trial?

Dr. Bartosz Chmielowski is an assistant clinical professor of medicine the University of California, Los Angeles' oncology department.  He treated both McLaughlin and Ryan and says, "I'm kind of torn apart a little bit...we recognize that more clinical trials trials should be designed in a different way."  Chmielowski says, "On one side, [there's] society as a whole.  On the other side, there's the patient in a doctor's office."